Journal Article puts cloud over Vioxx Trials

Merck suffered a public-relations nightmare last week when a respected medical journal said it had published misleading cardiovascular data about its painkiller Vioxx.

It only took a day for the embarrassing allegations to spill into the courtroom: On Friday, plaintiff attorneys in the first federal product-liability case involving Vioxx asked for a mistrial in Houston based on the new information. And lawyers who lost the first Vioxx lawsuit in New Jersey are said to be considering the inclusion of the material in their pending motion for retrial.

The real danger for Whitehouse Station-based Merck, however, is in the cases that lie ahead, legal experts say.

The company faces more than 7,000 state and federal lawsuits involving Vioxx, a painkiller once used by 20 million Americans. Vioxx was withdrawn from the market last year after prolonged use of the drug was linked to a greater risk of heart attack or stroke.

Merck has consistently argued that, as a century-old company dedicated to improving lives, it wouldn’t dare risk its reputation for a short-term boost in drug sales. But editors of the New England Journal of Medicine, perhaps the nation’s most highly regarded medical journal, on Thursday suggested Merck may have done just that by shading data in a major Vioxx study published five years ago.

“Doctors love Merck,” said Mike Ferrara, a Cherry Hill lawyer who will face off against Merck in a New Jersey Vioxx case in April. “However, when you mess around with the New England Journal and falsify stuff—anybody who was undecided, this is going to push everybody off the cliff.”

In an “expression of concern” that will appear in their Dec. 29 issue, the journal’s editors said the Vioxx study—called Vigor—failed to disclose three of 20 heart attacks suffered by people taking the drug. Someone using a Merck computer also deleted other information about Vioxx-related cardiovascular problems attributable to the painkiller from the manuscript of the article two days before it was submitted, they said.

The authors of the study, which included two Merck employees, have said they will publish a response to the journal’s editorial. Lead author Claire Bombardier told the Star-Ledger on Thursday the three excluded heart attacks came after a prespecified cut-off date for reporting data. She declined to comment further.

“I am first and foremost a scientist, and I will allow the data to speak for itself when it is complete,” she wrote in an e-mail.

Lawyers for Frederick Humeston, an Idaho man who lost a Vioxx case in Atlantic City last month, on Friday said they will consider adding the New England Journal revelations to their retrial motion, said Ferrara, who received an e-mail from them. The lawyers, Chris Seeger and David Buchanan, did not return phone calls.

Merck last week said it acted appropriately in disclosing data from Vigor. The company’s general counsel, Ken Frazier, declined to discuss the journal article while jurors continued to deliberate in the federal Houston case.

“The judge in the federal trial has asked the attorneys not to talk to the media,” Frazier said in an interview on Friday. “I’ll comment on that when the case is over.”

Because of the judge’s gag order, attorneys for both Merck and the plaintiffs declined to discuss the mistrial motion on Friday. The request was first reported by the Wall Street Journal and confirmed by a source close to the proceedings.

The judge did not immediately rule on the motion. The nine-member jury has deliberated for a little more than two days, including yesterday.

Ray Aragon, a Washington, D.C.-based lawyer who represents drugmakers against product-liability claims, said he was “kind of shocked” by the journal’s harsh assessment of the Vigor study.

“We can all agree Merck wishes it hadn’t happened,” he said. “It doesn’t change all that much the way they defend these cases, but now they have to defend themselves against allegations of cooking the data.”

Merck did have to defend the Vigor data in the Humeston case. But the person who testified about its flaws, University of Washington epidemiologist Richard Kronmal, was a paid expert witness for the plaintiff. The New England Journal criticisms are less open to challenge as an impartial source.

There could be other fallout from the editorial. Merck may have trouble recruiting some medical experts to testify on its behalf if its reputation has taken a hit, said Sam Davis, a Bergen County lawyer who has 100 Vioxx cases pending in Atlantic City.

“Doctors and researchers do not want to be associated with a pharmaceutical company that allows fraudulent data to be published in a peer review journal,” he said. “That’s a cardinal sin.”

In the end, however, jury selection in the individual cases can mean as much as any specific piece of evidence, no matter how damning, Ferrara said.

“If you have the right jury, you win,” he said.

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